Status:
COMPLETED
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The proposed study is a 12-week, open-label pilot study of sublocade (extended-release burprenorphine, BXR) as treatment for opiate use disorder (OUD) testing positive for Highly Potent Synthetic Opio...
Detailed Description
This is an open-label, uncontrolled pilot study. Outpatients seeking treatment for Opiate Use Disorder (OUD) will be screened, and those eligible who are positive for fentanyl analogues at screening w...
Eligibility Criteria
Inclusion
- Individuals between the ages of 18-65
- Voluntarily seeking treatment for opioid use
- Meets current DSM-5 (Diagnostic and Statistical Manual) criteria for Opioid Use Disorder (OUD) as a primary diagnosis, with at least moderate severity
- Test positive for Highly Potent Synthetic Opioids (HPSO) use
- Able to provide informed consent and comply with study procedures
Exclusion
- Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
- Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
- Methadone maintenance treatment
- Buprenorphine maintenance treatment
- Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients, male participants are required to use adequate forms of birth control as the exposure to Sublocade on sperm and subsequent fetal development are not known.
- Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure \>150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST (aspartate transaminase) and ALT (alanine aminotransferase) \>3 times the upper limit of normal
- Legally mandated to substance use disorder treatment
- Current physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary
- Individuals, who in the clinicians judgment, have a history of failed trial of buprenorphine or sublocade (e.g. history of severe opioid intoxication or overdoses despite adequate adherence to buprenorphine or sublocade), or other features of the history that strongly suggest the patient is not a good candidate for outpatient treatment with buprenorphine.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03861338
Start Date
March 1 2019
End Date
February 28 2020
Last Update
March 9 2021
Active Locations (1)
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1
Substance Treatment Research Service (STARS) of Columbia University
New York, New York, United States, 10019